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Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders

H

Heidelberg University

Status and phase

Completed
Phase 2

Conditions

Craniomandibular Dysfunction
Orofacial Pain

Treatments

Device: Michigan-type occlusal splint
Device: Grindcare

Study type

Interventional

Funder types

Other

Identifiers

NCT01949064
BioGC1UHeidelberg

Details and patient eligibility

About

The treatment of craniomandibular disorders is a challenging task. Many different treatments are yet available with occlusal splints being one of the most commonly used. A relative new diagnostic and treatment alternative is the Grindcare device. This enables the electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a certain limit. This stimulation results to a sudden break of the muscle activity.

Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our null-hypothesis was that there is no difference between the device and the splint in the reduction of pain intensity.

Enrollment

44 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent form
  • Age between 18 and 70 years
  • Non-chronic painful CMD with/without mandibular movement restriction
  • Female

Exclusion criteria

  • Pregnancy or breastfeeding
  • Chronic Pain Status higher than 2
  • Known allergic reaction against the gel pads
  • Electronic implants (pacemaker, defibrilator, insulin pump)
  • Facial pain of dental or neuropathic etiology
  • Traumatic injuries of the face / operations
  • Dental treatment need
  • Problems with swallowing reflex

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

Michigan-type occlusal splint
Active Comparator group
Description:
Occlusal splint, Michigan-type
Treatment:
Device: Michigan-type occlusal splint
Grindcare
Active Comparator group
Description:
Biofeedback device
Treatment:
Device: Grindcare

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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